Leonard 0600630Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741051944), received between Feb 3, 2016 and Aug 10, 2023 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Difficult to Flush; Fracture; Difficult to Flush; Fracture

  IT WAS REPORTED THAT ONE MONTH AND FOUR DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY NOT FUNCTIONING APPROPRIATELY. IT WAS FURTHER REPORTED THAT THE PORT MOST LIKELY WOULD NOT FLUSH. REPORTEDLY, LUMEN WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497924 ↗
• MalfunctionJul 24, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FIVE MONTHS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A HOLE IN THE LUMEN. IT WAS FURTHER REPORTED THAT THE PATIENT NO LONGER NEEDED TREATMENTS AND UNDERWENT SURGERY TO REMOVE THE DEVICE COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377374 ↗
• MalfunctionJul 24, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT TWO WEEKS AND FIVE DAYS POST A CHRONIC CATHETER PLACEMENT, THE WHITE LUMEN ALLEGEDLY HAD A SPLIT DURING USE. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376954 ↗
• MalfunctionJul 24, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ONE MONTH AND THIRTEEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE WHITE LUMEN ALLEGEDLY BROKE. REPORTEDLY, THE LUMEN WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376930 ↗
• MalfunctionJul 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE MONTH AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE RED LUMEN HOLE ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376895 ↗
• MalfunctionJul 21, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY FOUND TO BE BROKEN DURING A BLOOD WORK. IT WAS FURTHER REPORTED THAT THE LINE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370262 ↗
• MalfunctionJul 21, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE MONTH AND SEVEN DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD HOLE ABOVE THE HUB. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368746 ↗
• MalfunctionJul 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE HUNDRED AND FIFTY EIGHT DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A CRACK IN THE WHITE PATHWAY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315338 ↗
• MalfunctionJun 28, 2023Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, A SMALL HOLE WAS ALLEGEDLY NOTED WHEN FLUSHING. REPORTEDLY, THE LINE WAS CLAMPED AND OCCLUSIVELY COVERED, AND THE PROCEDURE WAS COMPLETED BY AN EXTERNAL LENGTH REPLACEMENT KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214721 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY TWO WEEK AND ONE DAY POST CATHETER PLACEMENT, THE PATIENT EXPERIENCED MINIMAL PAPULAR DERMATITIS WITH POST-INFLAMMATORY HYPERPIGMENTATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Rash

  MAUDE report 11452402 ↗
• MalfunctionJan 14, 2020Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600630 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FAILURE TO INFUSE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586738 ↗
• InjuryAug 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT APPROXIMATELY SEVEN WEEKS AFTER THE PLACEMENT OF THE CHRONIC CATHETER VIA THE LEFT SUBCLAVIAN VEIN, THE HEALTH CARE PROVIDER DECIDED TO REMOVE THE CHRONIC CATHETER DUE TO THE COMPLETION OF THE TREATMENT. IT WAS FURTHER REPORTED THAT DURING THE DEVICE REMOVAL PROCEDURE, THE HEALTH CARE PROVIDER ALLEGEDLY FINDS RESISTANCE WHILE PULLING THE CATHETER, HOWEVER, WHEN THE CATHETER WAS FINALLY RELEASED THE CUFF WAS DETACHED FROM THE CATHETER AND RETAINED IN THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED DISCOMFORT FROM PULLING THE CATHETER, HOWEVER, THE PATIENT REPORTED TO BE IN THE STABLE CONDITION AFTER THE DEVICE REMOVAL PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 8870798 ↗
• MalfunctionApr 18, 2019Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0600520 CHRONIC CATHETER EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529589 ↗
• MalfunctionDec 13, 2018Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST IMPLANT OF THE CHRONIC CATHETER, THE LINE ALLEGEDLY BURST WHILE FLUSHING CLAMPED ABOVE OPENING. IT WAS FURTHER REPORTED THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160949 ↗
• MalfunctionNov 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN FLUSHING THE CATHETER, A TEAR OCCURRED IN THE LINE CAUSING SALINE TO SPRAY ONTO THE PATIENT. IT WAS ALSO REPORTED THAT AFTER THE TEAR OCCURRED, BLOOD STARTED COMING OUT OF THE CATHETER. THE LINE WAS CLAMPED PROXIMAL TO THE TEAR TO PREVENT FURTHER BLOOD FROM LEAKING. THE LINE WAS REMOVED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087924 ↗
• MalfunctionNov 2, 2018Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE NURSE FLUSHED THE LINE IT RUPTURED. THE LINE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033497 ↗
• MalfunctionOct 18, 2018Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE OF THE CATHETER LINES PERFORATED DURING ADENOSINE ADMINISTRATION, REPORTEDLY DUE TO HAVING TO PUSH THE ADENOSINE FAST. THE OTHER LUMEN WAS REPORTED TO BE STILL PATENT AND WAS ABLE TO BE USED. THE LINE WAS CLAMPED AND THE NEXT DAY THE LINE WAS EXCHANGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979233 ↗
• MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE LINE FOUND DURING LAB DRAWS/FLUSHING. THE LINE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936709 ↗
• MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING FLUSHING OF THE CATHETER, THE RED LUMEN WAS FLUSHED AND HAD NO RETURN AND THE BLUE LUMEN WAS STIFF TO FLUSH. THE RN PUSHED HARDER AND THE LINE BURST AT THE HUB. THE LINE WAS IMMEDIATELY CLAMPED. THE LINE WAS REPLACED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936696 ↗
• MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE TRIED TO FLUSH THE LINE AND IT WAS REPORTEDLY OCCLUDED. THE NURSE HAD THE PATIENT TURN THEIR HEAD AND COUGH AND WAS THEN ABLE TO PUSH THE PLUNGER SOME. THE NURSE APPLIED A LITTLE MORE PRESSURE AND THE WHITE LUMEN POPPED. THE LINE WAS REMOVED AND PICC WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936694 ↗
• MalfunctionSep 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER BALLOONED WHILE IT WAS BEING FLUSHED AND THE LINE CRACKED. THE CATHETER WAS REMOVED AND A PICC WAS PLACED THE FOLLOWING DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918333 ↗
• MalfunctionSep 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BULGE WAS NOTED IN ONE OF THE LUMENS WHILE FLUSHING THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918332 ↗
• MalfunctionSep 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RED LUMEN WAS FLUSHED WITH 10 ML OF SALINE AND APPROXIMATELY 2 ML OF THE SALINE LEAKED OUT ONTO THE PATIENT¿S SHIRT. THE LINE WAS INSPECTED AND IT WAS REPORTED THAT A PUNCTURE/HOLE WAS LOCATED IN THE LINE. THE CLAMP WAS MOVED UP ABOVE THE SITE WHERE THE LINE HAD LEAKED. THE CATHETER WAS REMOVED AND A PICC WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918331 ↗
• MalfunctionSep 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE POPPED/BURST WHEN FLUSHED WITH SALINE. THE LINE WAS CLAMPED AND REPLACED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918330 ↗
• MalfunctionSep 28, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER IS STARTING TO BALLOON, BUT HASN¿T RUPTURED. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918209 ↗